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Phase I Study of Lonafarnib (SCH66336) and Gleevec (Imatinib Mesylate) in Chronic Myelogenous Leukemia (CML)


Phase 1
16 Years
N/A
Not Enrolling
Both
Chronic Myelogenous Leukemia

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Trial Information

Phase I Study of Lonafarnib (SCH66336) and Gleevec (Imatinib Mesylate) in Chronic Myelogenous Leukemia (CML)


Existing pre-clinical and clinical data suggest that SCH66336, a farnesyl transferase
inhibitor,exhibits significant activity against CML cells, and in fact may have synergistic
activity in combination with imatinib mesylate. Thus, the objectives to the study are (1) to
determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of lonafarnib
(SCH66336), a farnesyl transferase inhibitor, in combination with imatinib mesylate
(Gleevec) in patients with chronic phase, accelerated phase, and blast crisis CML; (2) to
assess the pharmacokinetics of the combination of lonafarnib and Gleevec in these patients;
and (3) to assess in a preliminary way the biologic activity of the combination of
lonafarnib and Gleevec in these patients.

Inclusion Criteria


1. Patients with Philadelphia chromosome (ph) positive CML in any of the following
categories:

1. Chronic phase patients must have failed therapy with Gleevec. Failure will be
defined as: (i) Patients who have not achieved or have lost their hematologic
response at 3 months from the start of therapy with Gleevec, or (ii) Patients
who have not achieved or have lost their cytogenetic response after 6 months of
therapy with Gleevec, or (iii) Patients who have not achieved or have lost their
major cytogenetic response after 12 months of therapy with Gleevec.

2. Patients in accelerated phase, defined as the presence of any of the following
features: (i) blasts in peripheral blood (PB) or bone marrow (BM) >/= 15% (but <
30%), (ii) blasts + promyelocytes in PB or BM >/= 30%, (iii) basophils in PB or
BM >/= 20%, (iv) platelets < 100 x 10e9/L unrelated to therapy, (v) clonal
evolution.

3. Patients in blast phase, defined by the presence of >/= 30% blasts in peripheral
blood and/or bone marrow, or the presence of extramedullary disease.

2) Patients in accelerated or blastic phase are eligible whether they have
received and/or failed Gleevec or not.

3) Age >/= 16 years.

4) Patients must sign an informed consent indicating that they are aware of the
investigational nature of this study in keeping eith the policies of the
hospital. The only acceptable consent form is attached at the end of the
protocol.

5) Performance status
6) Patients must have adequate hepatic functions (bilirubin renal functions (creatinine
7) Exclusion criteria:

1. Patients with QTc > 500 msec.

2. Patients with severe heart disease (cardiac class III and IV) will be excluded.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose Limiting Toxicity (DLT)

Outcome Description:

Dose-Limiting Toxicity (DLT) defined as grade 3 or 4 non-hematologic toxicity (NCI common criteria, version 2.0). Grade 3 or 4 nausea and vomiting considered DLT only if uncontrolled by antiemetics. Grade 3 or 4 diarrhea considered DLT only if uncontrolled for 48 hours despite adequate antidiarrheal therapy.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Jorge E. Cortes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ID02-221

NCT ID:

NCT00047502

Start Date:

November 2002

Completion Date:

April 2006

Related Keywords:

  • Chronic Myelogenous Leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

M.D. Anderson Cancer CenterHouston, Texas  77030